0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

Phase 3 Completed 110 enrolled The Hospital for Sick Children

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to compare the mean serum sodium at 48 hours following the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in children requiring maintenance IV fluid administration.

Timeline

Start: 2007-12
Primary completion: 2012-09
Completion: 2012-09

Publications

Friedman JN, Beck CE, DeGroot J, Geary DF, Sklansky DJ, Freedman SB. Comparison of isotonic and hypotonic intravenous maintenance fluids: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):445-51. doi: 10.1001/jamapediatrics.2014.3809.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	sodium chloride	Unknown	0.45 %	Intravenous
Comparator	sodium chloride	Unknown	0.9 %	Intravenous
Comparator	Dextrose	Unknown	5 %	Intravenous

Indications

No indication recorded.